Senior Regulatory Affairs Associate, CMC Biologics - US or Canada

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

We're looking for skilled CMC Biologics Regulatory experts to join a large, dedicated Functional Service Provider (FSP) program supporting a global biopharma leader!

If you're passionate about regulatory strategy and thrive in the dynamic world of biologics and vaccines, this is your opportunity to make a real impact. You'll contribute to both early-stage development and approved programs, helping to shape the future of life-saving therapies.

As a CMC Regulatory Affairs Senior Associate, you will play a critical role in shaping and executing global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies. You will support both early-stage development programs and marketed products, ensuring compliance with global regulatory requirements and facilitating successful product development and lifecycle management.

Key Responsibilities

• Develop and implement comprehensive global CMC regulatory strategies for investigational and commercial products.

• Author, review, and manage regulatory submissions including INDs, IMPDs, Annual Reports, post-approval changes, and responses to health authority queries.

• Lead cross-functional submission planning meetings and coordinate input from key stakeholders.

• Perform regulatory assessments of manufacturing and process changes, ensuring alignment with global regulatory expectations.

• Provide expert guidance on the regulatory implications of proposed changes to manufacturing, testing, and packaging.

• Represent Regulatory CMC on cross-functional project teams and contribute to strategic decision-making.

• Maintain up-to-date knowledge of global CMC regulatory requirements, guidelines, and industry trends.

• Collaborate closely with R&D, Manufacturing, Quality Assurance, and Clinical Development teams to support product development and lifecycle management.

Qualifications

• Bachelor's degree in a scientific discipline (advanced degree preferred).

• 4+ years of experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry.

• Proven experience authoring and reviewing regulatory submissions for both investigational and marketed products.

• Strong understanding of global regulatory requirements and guidelines (e.g., FDA, EMA, ICH).

• Excellent communication, organizational, and project management skills.

• Ability to work independently and collaboratively in a fast-paced, cross-functional environment.

• Ability to work EST hours (candidates based in the EST of the US or Canada are preferred, but consideration will be given to strong candidates in other N. American time zones who can work EST hours)

• The ability to travel 15-20% may be required

Ideal Candidate Profile

We seek individuals who embody a unique blend of qualities essential for success in the dynamic field of CMC Regulatory Affairs:

• Previous CMC biologics experience is required

• Technical Proficiency: Deep understanding of pharmaceutical development, manufacturing processes, and quality systems.

• Regulatory Expertise: Comprehensive knowledge of global CMC regulatory requirements and submission processes.

• Strategic Thinking: Ability to develop and implement innovative regulatory strategies aligned with business objectives.

• Leadership: Proven track record of guiding cross-functional teams and influencing decision-making at various organizational levels.

• Communication: Exceptional written and verbal skills for effective interaction with internal teams, external partners, and regulatory authorities.

• Adaptability: Flexibility to navigate evolving regulatory landscapes and shifting priorities.

• Problem-Solving: Strong analytical skills and innovative approaches to addressing complex regulatory challenges.

• Project Management: Capability to manage multiple complex projects simultaneously while maintaining attention to detail.

• Industry Passion: Genuine enthusiasm for contributing to successful product development and regulatory submissions in the pharmaceutical sector.

Why Join Us?

• Be part of a mission-driven organization focused on innovation and patient impact.

• Work with a collaborative and experienced team of regulatory professionals.

• Enjoy opportunities for professional growth and development.

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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.